GW Pharma plunges as cannabis drug trial disappoints

They should administer sativex with a diet rich plant fats from the actual food and lecithin because the nerves are high in these type of fats and cannabis would aid in the recovery process. Cannabis alone won't do it.

http://www.reuters.com/article/healthNews/idUSWLB949020080408

By Jonathan Saul

LONDON (Reuters) - Britain's GW Pharmaceuticals said its pioneering cannabis-based medicine failed to show significant improvement in a final stage trial to treat neuropathic pain in multiple sclerosis (MS) patients.

GW shares plunged as much as 31 percent to a four-month low of 49 pence on Tuesday following the latest setback for its biggest drug hope, Sativex. Its stock was 21 percent lower by 0951 GMT.

GW said Sativex had a very high patient response rate in the trial but that the results narrowly failed to reach statistical significance due to an unexpectedly large placebo response.

"While valid, this indicates that the effect of Sativex is marginal, and we retain our doubts as to whether the product will ever prove a commercial success," KBC Peel Hunt analyst Paul Cuddon wrote in a research note.

Nomura analyst Gary Waanders described the result as disappointing.

GW's managing director Justin Gover said there was a "desperate need" for new pain treatments and Sativex had a "real role" to play.

"The commercial proposition is not in question," Gover told Reuters. "It is a hazard of pain research that placebo effects occur in clinical trials and Sativex has seen this with this study."

GW, which grows thousands of marijuana plants at a secret location in the English countryside, said it would have to carry out another study in neuropathic pain.

"What this means is we are not able to speed things up," a GW spokesman added.

The study was one of three final Phase III trials for Sativex taking place this year.

GW said its study into spasticity in MS patients, requested by the UK regulator, was on track to report later this year. It also has a trial into cancer pain running in the United States also due in 2008.

"Our confidence in the outcome of our ongoing spasticity and cancer pain studies is not affected by these results. Neither is our approach to gaining regulatory approval," Stephen Wright, GW's director of research and development, told an analysts' call.

Sativex, which is sprayed under the tongue, became the first cannabis-derived medicine to win regulatory approval when it was approved in Canada in 2005 as a treatment for neuropathic, or nerve, pain in MS patients.

But the drug has been hit by a string of delays in Europe, where GW originally hoped to win approval in 2003.

The medicine needs to be attenuated with other treatments, physical therapy, biofeedback,ect.

I don't know why people are not getting excited about this GW study:

Highly Promising Results for New GW Cannabinoid Treatments for Diabetes and Related Metabolic Disorders

22/01/2008


Preparations underway for commencement of Phase II trials in 2008

Porton Down, UK, 22 January 2008: GW Pharmaceuticals plc (AIM: GWP) announces that it has generated highly promising results in both pre-clinical pharmacology studies and a Phase I trial of a new potential cannabinoid treatment for type 2 diabetes and related metabolic disorders. This research is part of a programme being conducted by GW to evaluate selected cannabinoids in a range of therapeutic areas.

GW’s initial cannabinoid target in this field, delta-9-tetrahydrocannabivarin (THCV), has successfully completed extensive pre-clinical pharmacology studies and its first Phase I clinical trial.

The pre-clinical studies have yielded highly promising findings. Recent results in several models of diabetes show desirable effects on plasma insulin, leptin and adiponectin levels, hormones of particular relevance to the development and treatment of diabetes, especially in obese individuals. In addition, we have seen a reduction in total cholesterol with an increase in the proportion of HDL (good) cholesterol.

The recently completed Phase I trial was a randomised, double blind, placebo controlled, dose escalation, safety and tolerability study of single doses of THCV in twelve healthy volunteer subjects. This trial showed that the study medication was well tolerated at target therapeutic doses and demonstrated a satisfactory safety profile.

Following on from this first study, GW is now preparing for a Phase IIa multiple dose study in type 2 diabetic patients in 2008.

These recent results add to previous findings showing effects on body weight, body fat content, energy expenditure, food intake, and other obesity-related parameters.

Dr Stephen Wright, R&D Director of GW, said, “These new results confirm that GW’s proprietary plant-based cannabinoids have significant potential as treatments in this important branch of therapeutics. We are now ready to build upon the pre-clinical data, as well as the Phase I trial results, by entering Phase II proof of principle studies during 2008.”

Dr Geoffrey Guy, Chairman, said, ”This exciting research programme is a further example of the range of potential for GW’s cannabinoids as new medicines. We believe that our research in the field of metabolic disorders represents a significant opportunity for GW and that it has the potential to be an important new area for future collaboration with partners.”


http://production.investis.com/gwp/...ss/2008-01-22a/

Too bad they didn't get results with this study. I've had many people with AIDS and diabetes and other problems swear to me privately that cannabis is a life-saver for neuropathic pain. They didn't have an agenda, they were just looking for something that works.

GW's struggles illustrate the real problems with getting medical MJ to become a viable product for a typical Big Pharma corporation. It just doesn't fit that business model for many reasons.

Obviously most of the political and media establishment and Big Pharma and its corrupt regulatory apparatus are all opposed to medical MJ becoming a viable corporate commercial product.

But there are lots of other problems, mostly related to the fact that medical cannabis is herbal medicine. Herbal medicine is most effective as a whole-plant extract. Herbal medicines are very complex combinations of many different natural chemicals acting in concert in the human body. The combination of different chemicals can vary depending the strain of plant or how it was grown.

Big Pharma's usual approach is to find a single active ingredient in a plant and then standardize it or synthesize it in an oral capsule. They tried that with Marinol and it doesn't work well. It's only one cannabinoid, THC, and it's only available via oral delivery.

GW is trying to work towards a natural extract of all the cannabinoids together, but I believe the current drugs they're testing are only a combination of 2 or 3 cannabinoids. There are over 60 cannabinoid chemicals in cannabis. Also, GW will only offer 1 delivery method, while natural cannabis patients are free to use many different methods of delivery and/or extraction.

What we have to ask ourselves as a global society is this: is the only way we're allowed to use a natural substance or plant is if a giant corporation with the proper connections ($$) to the corrupt government can make millions of dollars off it? I hope not, that is a bizarre sort of techno-slavery that does not bode well for our future.

In fact, this system, which was built on the promise of safe, pure medicines and miraculous new wonder drugs, actually seems to be causing us as a society to become fatter, sicker, and less healthy overall. In another generation, one-third of the elder population might have diabetes. That is a horrible failure, and I think we'll see more if we can't break this corrupt and evil strangle-hold on health care and medicine.

it's the difference between opium and heroin, or marinol and some bud.

In one, you get the full spectrum of active chemicals, and in the other, just 1 chemical.

The problem is finding out how those chemicals interact with one another, and what ratios are optimal for treating what conditions and symptoms.

Regardless, we've seen it before. Methadone is "legal" (and used at for profit clinics) but heroin is not. Marinol is schedual III (not even II) yet marijuana is I up there with heroin and LSD as being classified by the US government as having "no medicinal value".

It's so assbackwards.

on the one hand, we want them to succeed just so there is more pro-MJ research out there. But on the other hand, fuck'em. We know how to take MJ as a medication, and it involves trying different strains and seeing what works best for you. All with no licensing. But when the GW guys talk of "GW’s proprietary plant-based cannabinoids", I can only see a blatant effort to patent the naturally occuring cannabinoids to increase shareholder value and profits. And that I cannot support, total bullshit. Forcing MJ into the existing pharma model is like trying to push the square block through the round hole. And it takes a public domain product--if only because of prohibition--and makes it "proprietary", a la monsanto and round-up, and, well, fuck that.

Sorry it didn't work out, GW. Maybe you can join the seed selling underground and let some real growers, breeders and patients work with some of your special CBD and THCV strains. I'm sure we could find something great for patients that also smells and tastes great as a SMOKE. Oral spray, gimme a break...

I think that the more people understand that marijuana can be used for things like cancer and diabetes, the faster the fed will back off.

I'm not in favor of big pharma. I just like to use their proof that pot works.

Dam thats a bummer, Wonder what they where doing wrong, maybee the strain their using .

I haven't researched it lately, but the last time I checked GW was using a mix of THC and CBD. They were trying 3 different ratios, but only of those 2 cannabinoids.

I lost all faith in GW once they hired Andrea Barthwell. Fuck them. She is a totally evil, professional liar, trying to make money on the backs of the sick and dying. Anyone that would pay her and bring her into their company will do anything they need to to make money.

If and when GW becomes commercially viable, you can expect a big chunk of their profits to go towards sustaining cannabis prohibition, medical and otherwise.

Muleskinner said:

I haven't researched it lately, but the last time I checked GW was using a mix of THC and CBD. They were trying 3 different ratios, but only of those 2 cannabinoids.

I lost all faith in GW once they hired Andrea Barthwell. Fuck them. She is a totally evil, professional liar, trying to make money on the backs of the sick and dying. Anyone that would pay her and bring her into their company will do anything they need to to make money.

If and when GW becomes commercially viable, you can expect a big chunk of their profits to go towards sustaining cannabis prohibition, medical and otherwise.

Click to expand...

There have been two different diabetic trials underway.

One with THC+CBD for nuropathic pain. (this one sounds like they got their medicine mixed up with their placibo stuff)
The other with THCV for diabetes itself. (great results so far)

It will be a lot easier to support companies like GW once cannabis is freely available to all.

I think that the recent ACP endorsement was really interesting if you read the fine print. I think it went well beyond acknowledging the medical utility of cannabis.

I think it signaled that doctors and other medical professionals are starting to realize that the benefits of medicinal cannabis will never be fully realized until recreational prohibition ends. Once a doctor learns about cannabis and gets experience using it successfully with patients, they quickly learn that there is an enormous group of companies and govt. agencies with vested interests against legal marijuana, and they won't stop at anything to keep it illegal, including screwing over the sick and dying.

Research and development of individual cannabinoids WILL produce non-toxic miracle drugs that are more effective than raw natural cannabis - I believe that. But GW hiring and paying someone like Andrea Barthwell? That shows me that buying into and participating in the current prohibition scheme is more important to them then curing people.

Wow, this is really interesting, I just looked up a few of the cannabinoids on Wikipedia. It's going to be decades before we get even close to understanding the medical properties each one.

I wonder how much it would cost to send a small sample of cannabis to a lab to get a mass-spec analysis of cannabinoid content. This is what we'll really need in the future, when the medical properties of each cannabinoid are well-known.

If you knew someone with cancer, it'd be great to be able to grow them a strain you knew was high in CBD and others that would kill the cancer and also mitigate the "high" effect of THC. But this knowledge is the most valuable thing, not the actual Pharma drug that will come from it.

That's what I"m afraid of, I fear that this type of discovery will be accompanied by political efforts to create a model where only Big Pharma can provide these meds legally. One could even imagine a world where different strains of herb are patented and not allowed for the general population.

Ultimately, it's not just the medical efficacy of cannabis that is the miracle. It's the accessiblity of it. Anyone can take the seeds and produce the medicine relatively easily. I'm afraid that any entity seeking to exploit the first property will try to restrict the second.

i.e., once GW discovers and tells the world that THCV cures diabetes (I hope they do), they will have to make moves to keep all of us from simply going to Dutch Passion and ordering a pack of THCV-heavy seeds for $50.

Oh I understand!!

I just like to use these vested interests to promote mmj itself.

And I'm about 99% in agreement with you.

Welcome (back??) Muleskinner!

Welcome (back??) Muleskinner!

Yer knowledge and point-of-veiw is awsome! I sure hope ya stick around fera while...Take care,BC

Hey I hope you guys are right and I am overly paranoid. It would be good if a pharmaceutical company proved the benefits of cannabis, and GW is using whole plant extracts. Only time will tell!

So far I can't see that they've done any damage. But this is what scares me - from their website (some great info on there). I wonder if Ethan Russo from Montana is still involved? If he is then GW is not a lost cause, he is a very good person.


from the website:


GW adopts an aggressive approach to securing intellectual property rights to protect techniques and technologies involved in the development programme. Protection is sought in the areas listed below:

• Plant variety rights
• Methods of extraction patents
• Drug delivery patents
• Patents on compositions of matter for delivery of cannabis
• Methods of use patents
• Design copyright on devices
• Trademarks

In the last few years our intellectual property portfolio has developed considerably. The patent portfolio has more than doubled in size and comprises 42 patent families, within these families there are numerous granted patents both in the UK and in various territories around the world. GW has also developed a trademark portfolio of 21 UK registered trademarks with equivalent marks registered in many other territories around the world. GW also holds nine registered design rights and nine plant variety rights.

GW Pharma's cannabis drug fails in cancer pain study, shares fall

GW Pharma's cannabis drug fails in cancer pain study, shares fall

http://www.reuters.com/article/2015/01/08/us-gw-pharma-epilepsy-idUSKBN0KH13U20150108